EU Cosmetics Regulation
What is the EU Cosmetics Regulation (EC 1223/2009)?
The EU Cosmetics Regulation, formally known as Regulation (EC) No 1223/2009, is the primary legal framework governing cosmetic products placed on the European Union market. It sets out the safety, labelling, and notification requirements that manufacturers, importers, and distributors must meet before a cosmetic product can be lawfully made available to EU consumers. The regulation applies to all cosmetic products as defined within its scope, regardless of where the manufacturer is based.
Why It Matters
The EU Cosmetics Regulation establishes a comprehensive framework designed to ensure that cosmetic products are safe for human health when used under normal or reasonably foreseeable conditions. It places clear obligations on responsible persons, manufacturers, importers, and distributors, and requires that every cosmetic product placed on the EU market is notified through the Cosmetic Products Notification Portal (CPNP) before it goes on sale.
For non-EU manufacturers, the regulation requires that a Responsible Person established within the EU is designated for every cosmetic product placed on the market. Without a Responsible Person, a cosmetic product cannot lawfully be sold to EU consumers, whether through physical retail or online channels.
For cosmetic brands, manufacturers, and ecommerce sellers, understanding and complying with the EU Cosmetics Regulation is essential for lawful access to the EU market.
Key Requirements
Who Does the EU Cosmetics Regulation Apply To?
The regulation applies to any person involved in placing cosmetic products on the EU market, including:
- Responsible Persons — the EU-established entity accountable for compliance of each cosmetic product placed on the market
- Manufacturers — those who produce cosmetic products and place them on the market under their name or trademark
- Importers — EU-established entities that place cosmetic products from third countries onto the EU market
- Distributors — any person in the supply chain who makes a cosmetic product available on the EU market
This requirement applies under:
- Regulation (EC) No 1223/2009 — EU Cosmetics Regulation
Responsibilities Under the EU Cosmetics Regulation
While specific obligations depend on the role in the supply chain, responsibilities commonly include:
- Designating an EU Responsible Person for every cosmetic product before it is placed on the market
- Notifying the product on the Cosmetic Products Notification Portal (CPNP) prior to placing it on the market
- Ensuring the product has a completed Cosmetic Product Safety Report (CPSR)
- Maintaining a Product Information File (PIF) for each cosmetic product
- Ensuring labelling meets all applicable requirements, including ingredient listing and any required warnings
- Reporting serious undesirable effects to the relevant competent authority
- Cooperating with market surveillance authorities upon request
EU Cosmetics Regulation and the Responsible Person
Under Article 4 of the regulation, every cosmetic product placed on the EU market must have a designated Responsible Person established within the EU. The Responsible Person is the primary point of accountability for the product’s compliance and must be identified on the product label.
For non-EU manufacturers, appointing an EU Responsible Person is a mandatory step before any cosmetic product can be placed on the EU market. This role is separate from equivalent obligations under other EU regulations, and businesses selling cosmetics alongside other product categories must address each framework independently.
Need EU cosmetics compliance support?
Euverify provides Responsible Person services for cosmetic brands and manufacturers placing products on the EU market under the EU Cosmetics Regulation. Our team supports CPNP notification, product information file management, regulatory communication, and ongoing compliance management.
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